Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Aug 30, 2026•1 min read
FDA Discontinues Methotrexate Sodium Injection (ANDA089309)
The FDA has listed Quad Pharms' methotrexate sodium injection (product 001) as discontinued under ANDA089309.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA 088622 for Amitriptyline Hydrochloride 50 mg Tablet (Watson Labs)
The FDA granted approval for ANDA 088622, an oral 50 mg Amitriptyline Hydrochloride tablet submitted by Watson Labs; the product is listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
MFDS Revises Enforcement Regulations to Strengthen R&D Oversight
MFDS amended the Regulatory Science Innovation Act rules, clarifying its head's authority over R&D project selection and updating agency titles, effective immediately.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Teva Hydrochlorothiazide 50 mg Tablet (ANDA 088923)
The FDA approved Teva’s ANDA 088923 for a 50 mg oral hydrochlorothiazide tablet; the product is listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
Unexpected Shutdown of Carestation 850 Anesthesia Systems When AC Power Is Lost
Health Canada alerts that Carestation 850 and 850C anesthesia systems may shut down unexpectedly if AC mains power is disconnected or lost.
Regulatory Updates
Aug 30, 2026•1 min read
Gentherm Medical Reports Overheated Circuit Boards in Some Devices
Gentherm Medical reports overheating in 0.53% of devices, potentially causing shutdowns, but no harm reported.
Regulatory Updates
Aug 30, 2026•1 min read
Unexpected Shutdown Risk for Carestation 850/850C Anesthesia Systems
Health Canada alerts that Carestation 850 and 850C anesthesia systems may shut down unexpectedly when AC mains power is lost.
Regulatory Updates
Aug 30, 2026•1 min read
Gentherm Medical Reports Overheated Circuit Boards in Blanketrol Devices
Gentherm Medical reports that 0.53% of Blanketrol RII 115V and RIII 115V devices have overheated circuit boards, potentially causing shutdowns. No injuries reported; users may continue use with caution.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Imipramine Hydrochloride (ANDA088292)
FDA grants approval for ANDA088292, an oral imipramine hydrochloride tablet by Strides Pharma Science Limited, with details on dosage, NDC codes, and submission history.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA081189 for Hydrochlorothiazide 25 mg Tablet by Watson Labs
The FDA granted original approval for ANDA081189, a 25 mg oral Hydrochlorothiazide tablet from Watson Labs, with multiple labeling supplements approved through 1995. The product is now discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
Mylan Discontinues Propoxyphene Hydrochloride 32 mg Oral Capsule (ANDA083528)
Mylan’s ANDA083528 for propoxyphene hydrochloride 32 mg oral capsules is listed as discontinued by the FDA.
Regulatory Updates
Aug 30, 2026•1 min read
KV Pharm’s Phendimetrazine Tartrate Tablet (ANDA 084138) Discontinued
The FDA records show KV Pharm’s oral tablet of Phendimetrazine Tartrate (35 mg) under ANDA 084138 is now listed as discontinued.